Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-04 @ 6:44 AM
Study NCT ID:
NCT05187468
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-09', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2022-01-09', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity on myofascial trigger points', 'timeFrame': 'baseline', 'description': 'Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)'}, {'measure': 'Pain intensity on myofascial trigger points', 'timeFrame': 'one week', 'description': 'Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)'}, {'measure': 'Pain intensity on myofascial trigger points', 'timeFrame': 'two weeks', 'description': 'Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)'}, {'measure': 'Pain intensity on myofascial trigger points', 'timeFrame': 'three weeks', 'description': 'Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)'}, {'measure': 'Pain intensity on myofascial trigger points', 'timeFrame': '1 month after', 'description': 'Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'baseline', 'description': 'Pain tolerance to compression. Measured in kilos'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'one week', 'description': 'Pain tolerance to compression. Measured in kilos'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'two weeks', 'description': 'Pain tolerance to compression. Measured in kilos'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'three weeks', 'description': 'Pain tolerance to compression. Measured in kilos'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'one month after', 'description': 'Pain tolerance to compression. Measured in kilos'}, {'measure': 'cervical range of motion', 'timeFrame': 'baseline', 'description': 'Goniometer (measured in degrees)'}, {'measure': 'cervical range of motion', 'timeFrame': 'one week', 'description': 'Goniometer (measured in degrees)'}, {'measure': 'cervical range of motion', 'timeFrame': 'two weeks', 'description': 'Goniometer (measured in degrees)'}, {'measure': 'cervical range of motion', 'timeFrame': 'three weeks', 'description': 'Goniometer (measured in degrees)'}, {'measure': 'cervical range of motion', 'timeFrame': 'one month after', 'description': 'Goniometer (measured in degrees)'}, {'measure': 'Northwick Park Neck Pain questionnaire', 'timeFrame': 'baseline', 'description': 'functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability'}, {'measure': 'Northwick Park Neck Pain questionnaire', 'timeFrame': 'one week', 'description': 'functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability'}, {'measure': 'Northwick Park Neck Pain questionnaire', 'timeFrame': 'two weeks', 'description': 'functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability'}, {'measure': 'Northwick Park Neck Pain questionnaire', 'timeFrame': 'three weeks', 'description': 'functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability'}, {'measure': 'Northwick Park Neck Pain questionnaire', 'timeFrame': 'one month after', 'description': 'functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myofascial Trigger points', 'upper trapezius', 'Myofascial pain syndrome', 'Mtrps'], 'conditions': ['Myofascial Pain Syndrome', 'Myofascial Trigger Point Pain', 'Upper Trapezius Trigger Points']}, 'descriptionModule': {'briefSummary': 'This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes.', 'detailedDescription': 'This study was a randomized controlled trial consisted of three intervention groups. Two of them recieved ESWT with different parameters in each group, while the third one was standard care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were divided randomly into the three groups. Participants were blind to the group allocated and also the therapist and outcome investigator were blind.\n\nThe participants recieved three weekly sessions. The evaluation took place before therapy, after each session and one month after last session.\n\nThe outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an algometer device, the range of motion of neck measured by electronic goniometer and and functionality of neck measured by the Northwick Park Neck Pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain between shoulder and neck on upper trapezius muscle\n* Three out of five of Travel and Simons criteria for myofascial trigger points\n\nExclusion Criteria:\n\n* Fibromyalgia diagnosis\n* Systemic diseases diagnosis,\n* Pacemaker, under 18,\n* Any kind of cervical disorder or surgery,\n* Mental disorders'}, 'identificationModule': {'nctId': 'NCT05187468', 'briefTitle': 'The Effectiveness of Radial ESWT on Upper Trapezius Mtrps', 'organization': {'class': 'OTHER', 'fullName': 'European University Cyprus'}, 'officialTitle': 'The Effectiveness of Radial Extracorporeal Shockwave on Upper Trapezius Myofascial Trigger Points', 'orgStudyIdInfo': {'id': 'EuropeanUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESWT 1', 'description': 'Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'ESWT 2', 'description': 'Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound therapy, Massage, Heat Pack', 'description': '10 Min massage 5 min US therapy 10 min Heat pack', 'interventionNames': ['Device: Ultrasound therapy, Massage, Heat pack']}], 'interventions': [{'name': 'Extracorporeal Shockwave Therapy', 'type': 'DEVICE', 'otherNames': ['ESWT', 'rSWT'], 'description': '1000 pulses at 60 mj, 10 Hz', 'armGroupLabels': ['ESWT 1']}, {'name': 'Extracorporeal Shockwave Therapy', 'type': 'DEVICE', 'description': '2000 pulses at 60 mj, 10 Hz', 'armGroupLabels': ['ESWT 2']}, {'name': 'Ultrasound therapy, Massage, Heat pack', 'type': 'DEVICE', 'description': 'Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack', 'armGroupLabels': ['Ultrasound therapy, Massage, Heat Pack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2404', 'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'European University Cyprus', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European University Cyprus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Rentzias Panagiotis', 'investigatorAffiliation': 'European University Cyprus'}}}}